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A prospective study of the efficacy and safety of preoperative chemotherapy with gemcitabine+nab-paclitaxel therapy for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image.

A prospective study of the efficacy and safety of preoperative chemotherapy with gemcitabine+nab-paclitaxel therapy for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image. - A prospective study of the efficacy and safety of preoperative chemotherapy for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image.

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000040948
Enrollment
53
Registered
2020-07-01
Start date
2020-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

None listed

Sponsors

Wakayama medical university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.In the case which the primary tumor is confirmed to be pancreatic cancer by histological diagnosis, cytological diagnosis, or image examination, the degree of progress diagnosis is performed by image examination, and it becomes resectable pancreatic body cancer according to NCCN guideline (Version 1.2020). Among the matching cases, resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image diagnosis. 2.Cases with measurable lesions 3.Initial treatment case 4.Cases with 0 or 1 Performance status (ECOG) 5.Cases with 20 years or older 6.Cases which the functions of major organs meet the following criteria (latest value within 14 days before registration) White blood cell: <12,000/mm3 Neutrophil: >1,500/mm3 Hemoglobin value: >9.0g/dL Platelet: >100,000 /mm3 Total bilirubin: less than 2.0 mg/dL (less than 3.0 mg/dl in jaundice cases) Serum creatinine: <1.5 mg/dL AST and ALT: 2.5 x below facility standard upper limit 7.Cases in which consent was obtained by the patient's signature before registration

Exclusion criteria

Exclusion criteria: 1. Cases with a history of severe drug hypersensitivity or drug allergy 2. Cases with a history of malignant tumor 3. Cases with active infection 4. Patients with peripheral sensory neuropathy (Grade 2 or higher) 5. Cases with a history of interstitial pneumonia or pulmonary fibrosis 6. Patients with uncontrolled ascites or pleural effusion 7. Cases with uncontrolled diabetes 8. Cases with Uncontrolled congestive heart failure, angina, hypertension, arrhythmia 9. Cases with history of neurologically or psychologically significant disease 10. Cases with diarrhea 11. Pregnant women, lactating women, and women who may be pregnant (will), or women and men who are not willing to contracept during the study period and for a certain period (180 days) after the last administration of study drug 12. Other cases that the doctor has determined to be unsuitable for participation in this clinical trial 13. Cases which conforms to Borderline Resectable/Unresectable of NCCN guidelines (Version 1.2020) by MDCT diagnosis. 14. Patients with active hepatitis B

Design outcomes

Primary

MeasureTime frame
Overall survival after initiation of protocol treatment—

Countries

Japan

Contacts

Public ContactYuji Kitahata

Wakayama medical university 2nd department of surgery

yuji-kh@wakayama-med.ac.jp0734410613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026